Clinical Research Directory

Florida Cerebrovascular Disease Biorepository and Genomics Center

The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. The information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.

Randomized Trial of Anticoagulation Plus Batroxobin for Acute Cerebral Venous Thrombosis

A total of 72 patients meeting the diagnostic criteria for acute cerebral venous thrombosis were included in this study. A multi-center stratified randomization method was adopted, with the stratification factor being each participating center. There were three groups in total, and within each group, the experimental group and the control group were assigned in a 1:1 ratio. Finally, all the experimental groups and control groups were combined to form the overall experimental group and control group. Random sequences were generated using a computer random number generator, and concealed allocation was implemented using sealed, opaque, consecutively numbered envelopes. Patients and their families, researchers, treating physicians and nurses, outcome assessors, and other personnel directly involved in the trial were unaware of the treatment allocation. Patients meeting the inclusion criteria for acute CVT were immediately given standard anticoagulant therapy (subcutaneous injection of low-molecular-weight heparin at a dose of 0.4 mg every 12 hours for 5-7 days). Subsequently, patients were randomly assigned to the experimental group and the control group. The experimental group received a combination of anticoagulants (low-molecular-weight heparin bridged to warfarin 3 mg/day, rivaroxaban 10-20 mg/day, or dabigatran 110-150 mg twice daily) and batroxobin (initial dose of 10 BU, followed by 5 BU every other day); the control group received only the aforementioned anticoagulants. Follow-up evaluations were conducted at 7 days, 30 days, and 90 days after baseline. Baseline data included demographic characteristics, routine laboratory tests (complete blood count, liver and kidney function tests, electrolyte analysis, urine analysis, and coagulation function), TOF MRV, NIHSS score, and mRS score. Follow-up data covered TOF MRV, NIHSS score, and mRS score at 7 days, 30 ± 7 days, and 90 ± 7 days for the treatment groups. NIHSS and mRS assessments were conducted by neurologists who were unaware of the treatment plan. To minimize potential bias in the primary outcome, qualified personnel at each research center reviewed the 90-day clinical evaluations according to a standardized procedure manual. To ensure the validity and reproducibility of the evaluations, training courses were held for all researchers at each center. In addition, researchers recorded in detail the concomitant medications and adverse events that occurred within 90 days after patient enrollment. The primary endpoint was the proportion of patients achieving recanalization within 7 days of treatment. Secondary endpoints included the proportion of patients achieving neurological improvement (NIHSS score reduction ≥ 2 points) or deterioration (NIHSS score increase ≥ 4 points) at 7 days, 30 days, and 90 days, the proportion of patients achieving functional improvement (mRS score reduction) within 90 days, and the occurrence of CVT recurrence or other vascular events within 90 days.

Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam

This prospective, single-arm observational cohort study aims to evaluate the real-world effectiveness and safety of direct oral anticoagulants (DOACs), specifically dabigatran or rivaroxaban, in patients with cerebral venous thrombosis (CVT). The study will be conducted at Bach Mai Hospital, a national tertiary stroke referral center in Hanoi, Vietnam. A minimum of 69 adults with radiologically confirmed CVT will be enrolled between June 2025 and June 2027. All participants must have received therapeutic-dose heparin during the acute phase and will be transitioned to a DOAC within 5 to 15 days, per physician judgment. All treatments are part of routine care; no investigational drugs are used. The primary outcome is a composite of major bleeding (per ISTH criteria) or recurrent venous thromboembolism (VTE) within 6 months. Secondary outcomes include: functional outcome (Modified Rankin Scale), venous sinus recanalization, all-cause mortality, serial D-dimer levels, post-CVT chronic headache, health-related quality of life (EQ-5D-5L), clinically relevant non-major bleeding (CRNMB), symptomatic recurrent VTE, arterial thrombotic events, and early treatment discontinuation. This study aims to generate real-world data supporting DOAC use in CVT, particularly in Asian populations where prospective evidence is limited.

Safety and Efficacy of Edoxaban and Rivaroxaban to Cerebral Venous Thrombosis in Chinese Patients

The goal of this observational study is to learn the safety and efficacy of edoxaban and rivaroxaban in Chinese population with the age range from 18 to 80 years who take edoxaban or rivaroxaban to treat their cerebral venous thrombosis (CVT). The main question it aims to answer are: * Do cerebral veins or venous sinuses recanalize during the treatment period of edoxaban and rivaroxaban? * Do the bleeding events occur during the treatment period of edoxaban and rivaroxaban? The main tasks participants will be asked to do: * Participants will comply fully with the prescribed regimen and take the edoxaban or rivaroxaban as directed at the specified dosage. * Participants will return to hospital for scheduled follow-up assessments at months 3, 6, 9, and 12 post-enrollment to undergo face-to-face visits with investigators.

Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis

Rationale: Patients with cerebral venous thrombosis (CVT) are currently treated with anticoagulants during 3-12 months after diagnosis, to prevent worsening of the CVT and recurrent thrombosis, and to promote venous recanalization. Until recently, patients were generally treated with vitamin K antagonists (VKA). Direct oral anticoagulants (DOACs) are more practical in use than VKA and carry a lower risk of intracranial hemorrhage (ICH) in other conditions. One of the burning clinical questions is whether CVT patients can be safely treated with DOACs instead of VKA. In 2019, the first randomized trial on the safety and efficacy of DOACs in CVT was published (RESPECT-CVT). This exploratory study included 120 patients and the results suggest that DOACs can be safely used to treat CVT. Following RESPECT-CVT, use of DOACs to treat CVT is expected to rise, but given the limited sample size and strict selection criteria of RESPECT-CVT, additional data regarding the efficacy and safety of DOACs in CVT are required, especially from routine clinical care. Objective: To assess the safety and efficacy of DOACs for the treatment of CVT in a real-world setting. Study design: DOAC-CVT is an international, prospective, comparative cohort study. Initially, DOAC-CVT was designed to recruit 500 patients in a three-year study period. All patients recruited until January 15, 2024 will be included in the primary data analysis as previously described (https://doi.org/10.3389/fneur.2023.1251581). In addition, we will continue patient recruitment in an extension of the study until January 2026 to have a larger sample size, add new research questions, and to further strengthen global. We aim to recruit 1300 patients and anticipating a 3:2 ratio in DOAC:VKA use, we expect that in total 780 patients treated with a DOAC will be included. Study population: Patients are eligible if they are \>18 years old, have a radiologically confirmed CVT, have started oral anticoagulant treatment (DOAC or VKA) within 30 days of CVT diagnosis, and are included in the study within 90 days after CVT diagnosis. Primary study endpoint: The primary endpoint is a composite of major bleeding (according to the criteria of the International Society on Thrombosis and Haemostasis) AND symptomatic recurrent venous thrombosis after 6 months of follow-up. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is an observational study which poses no risk or burden to the participant. Only data that are collected as part of routine clinical care will be used.

Rivaroxaban Versus Apixaban in Cerebral Venous Thrombosis

Along with the current clinical trial, the efficacy and safety of a 20 mg rivaroxaban administered within 24 hours of randomization after having first-ever cerebral venous thrombosis compared to apixaban 5mg Bid were assessed through rate of recurrent VTE, mRS, rate of venous recanalization, HIT score, MoCA test, and central and peripheral heamoragic complications.